The US FDA has approved Sculptra (injectable poly-L-lactic acid) of Dermik Laboratories, the US dermatology arm of Aventis as the only product for the restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Commercial availability of Sculptra is expected in the third quarter of this year.

"We are very pleased that the FDA has recognized the need for Sculptra with its expedited review and approval," said John Leone, president of Aventis Dermatology, a global unit of Aventis.

Sculptra is a synthetic and biocompatible material that is injected below the surface of the skin in the area of fat loss. It provides a gradual and significant increase in skin thickness, improving the appearance of folds and sunken areas. For most people who participated in a clinical study, the treatment results lasted for up to two years after the first treatment session, release from Aventis says.

"For years, people have tried a variety of procedures to correct sunken cheeks, hollow eyes, indentations, and other signs of facial fat loss-a common side effect of anti-retroviral therapy for human immunodeficiency virus. Until now, there have been no treatments approved by the FDA specifically for this condition," said Marcus Conant, clinical professor, UCSF Medical Centre. "Sculptra is a well-tolerated, breakthrough treatment that can be administered during an outpatient office visit and offers long-lasting results," he added.

More than 150,000 people in more than 30 countries worldwide have been treated with Sculptra, under the trade name New-Fill, for a variety of facial volume and contour deficiencies. It was approved in Europe in 1999 to increase the volume of depressed areas, particularly for the correction of skin depression, including skin creases, wrinkles, folds, scars, and eye rings. In 2004, the product was approved in Europe for large-volume corrections of the signs of lipoatrophy, the release added.

Because the main component in Sculptra, poly-L-lactic acid, is a polymer synthetically derived from natural components and is a biocompatible substance, there is no need to test for allergic reactions. Poly-lactic acid has been used in surgical products for more than 20 years as a component of dissolvable sutures and is used as a vehicle for several sustained-release injectable medications.

Facial lipoatrophy is the loss of fat beneath the skin, which can result in sunken cheeks, indentations, and hollow eyes.